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Endoscopic Stabilization Device Evaluation Using IDEAL Framework: A Quality Improvement Study

Sharma, Sam K; Momose, Kota; Sedrakyan, Art; Sonoda, Toyooki; Shariaha, Reem
OBJECTIVE:To determine whether clinical evaluation reporting using the IDEAL (Idea, Development, Exploration, Assessment and Long-term study) framework improves a novel double-balloon endoscopic stabilization technology. DESIGN/METHODS:Observational registry 6 month study with no follow-up. Using the Prospective Development Study (PDS) format recommended by the IDEAL collaboration, we report on continued refinement and optimization of an endoscopic stabilisation platform during a clinical study conducted by two clinicians from the first case onwards. Key outcomes (ability to reach cecum, inflation of balloons in the sigmoid and ascending colon, and complications) were prospectively reported for each patient sequentially. All changes to technique were highlighted, showing when they occurred and an explanation for the change. RESULTS:30 colonoscopies were undertaken using the device from April to September 2017. Two patients were excluded from the analysis for protocol deviations. Cecum was reached in 89% of the per protocol population of patients in an average time of 13.5 ± 11 minutes. Therapeutic zone creation was successful in 89% of patients on the right side of the intestine and 100% in those that reached the sigmoid. There were five deliberate changes in technique that occurred during the study that enabled improved device technical performance. There were no serious complications and one polyp was removed successfully using the device. Clinicians reported endoscope stability and increased visibility of the intestinal mucosa increased when using the device. CONCLUSION/CONCLUSIONS:The IDEAL framework provided a structured reporting of the changes made to technique. Those changes facilitated a device that is safe, has achieved stability with improved performance.
PMID: 30849526
ISSN: 1743-9159
CID: 3723652

Double-balloon platform-assisted rectal endoscopic submucosal dissection

Shah, Shawn L; Sharma, Sam; Dawod, Qais; Hajifathalian, Kaveh; Saumoy, Monica; Sonoda, Toyooki; Sharaiha, Reem Z
PMID: 29954007
ISSN: 1438-8812
CID: 3525462

A Rare Case of Interdigitating Dendritic Cell Sarcoma of the Rectum: Review of Histopathology and Management Strategy [Case Report]

Hirji, Sameer A; Senturk, James C; Hornick, Jason; Sonoda, Toyooki; Bleday, Ronald
Interdigitating dendritic cell sarcoma (IDCS) is a rare neoplasm arising from a subclass of dendritic cells, known for their role in mediating various immunological functions, including T-cell mediated immunity. Although existing literature on IDCS is limited to scattered reports, extranodal manifestation in the gastrointestinal tract, and in particular, the rectum is extremely rare. To our knowledge, we report only the second case of IDCS arising in the rectum in a young 20-year-old man, successfully managed surgically and with a good oncological outcome. Existing literature on the incidence, pathophysiology and treatment strategies is also examined.
PMID: 28784918
ISSN: 1757-790x
CID: 3525452

Readmission After Ileostomy Creation: Retrospective Review of a Common and Significant Event

Fish, Daniel R; Mancuso, Carol A; Garcia-Aguilar, Julio E; Lee, Sang W; Nash, Garrett M; Sonoda, Toyooki; Charlson, Mary E; Temple, Larissa K
OBJECTIVE:To evaluate causes and predictors of readmission after new ileostomy creation. BACKGROUND:New ileostomates have been reported to have higher readmission rates compared with other surgical patients, but data on predictors are limited. METHODS:A total of 1114 records at 2 associated hospitals were reviewed to identify adults undergoing their first ileostomy. Primary outcome was readmission within 60 days of surgery. Multiple logistic regression was used to identify independent predictors; area under the receiver-operator characteristic curves (AUC) were used to evaluate age-stratified models in secondary analysis. RESULTS:In all, 407 patients underwent new ileostomy; 58% had cancer, 31% IBD; 49% underwent LAR, 27% colectomy, and 14% proctocolectomy. Median length of stay was 8 days. Among the patients, 39% returned to hospital, and 28% were readmitted (n = 113) at a median of 12 days postdischarge. The most common causes of readmission were dehydration (42%), intraperitoneal infections (33%), and extraperitoneal infections (29%). Dehydration was associated with later, longer, and repeated readmission. Independent significant predictors of readmission were Clavien-Dindo complication grade 3 to 4 [odds ratio (OR) 6.7], Charlson comorbidity index (OR 1.4 per point), and loop stoma (OR 2.2); longer length of stay (OR 0.5) and age 65 years or older (OR 0.4) were protective. Cohort stratification above or below age 65 revealed that older patient readmissions were more predictable (AUC 0.84) with more preventable causes, whereas younger patient readmissions were difficult to predict or prevent (AUC 0.65). CONCLUSIONS:Readmissions are most commonly caused by dehydration, and are predicted by serious complications, comorbidity burden, loop stoma, shorter length of stay, and age. Readmissions in older patients are easier to predict, representing an important target for improvement.
PMID: 28059966
ISSN: 1528-1140
CID: 3525442

An Assessment of the Industry-Faculty Surgeon Relationship Within Colon and Rectum Surgical Training Programs

Patel, Sunil V; Klingel, Michelle; Sonoda, Toyooki
INTRODUCTION/BACKGROUND:Industry funding of surgical training programs poses a potential conflict of interest. With the recent implementation of the Sunshine Act, industry funding can be more accurately determined. OBJECTIVE:To determine the financial relationship between faculty surgeons within colon and rectal fellowship programs and industry. DESIGN/METHODS:Review of industry funding based on the first reporting period (August-December, 2013) using the Centers for Medicare and Medicaid Services online database. SETTING/METHODS:ACGME certified colon and rectum surgical fellowship programs. PARTICIPANTS/METHODS:Overall, 343 Faculty surgeons from 55 colon and rectum surgical fellowship programs were identified using the American Board of Colon and Rectum Surgery website. There was complete identification of faculty surgeons in 47 (85.5%) programs, partially complete identification (i.e., >80%) in 6 (10.9%) programs, and inadequate identification of faculty in 2 (3.6%) programs. MAIN OUTCOME/RESULTS:Industry funding as defined by the Sunshine Act included general payments (honorariums, consulting fees, food and beverage, and travel), research payments, and amount invested. RESULTS:In all, 69.1% of program directors and 59.4% of other faculty received at least one payment during the reporting period (Δ9.7%, 95% CI: -4.4% to 23.8%, p = 0.18). Program directors received higher amounts of funding than other faculty ($7072.90 vs. $2,819.29, Δ$4,253.61, 95% CI: $1132-$7375, p = 0.008). Overall, 49 of 53 (93%) programs had surgeons receive funding, with a median of 3.5 surgeons receiving funding per program. A total of 65 companies made payments to surgeons, with 80.1% of the funding categorized as general payments, 16.2% as investments, and 3.7% as research payments. CONCLUSIONS:Industry funding was common. This financial relationship poses a potential conflict of interest in training fellows for future practice.
PMID: 26966083
ISSN: 1878-7452
CID: 3525432

Systematic Video Documentation in Laparoscopic Colon Surgery Using a Checklist: A Feasibility and Compliance Pilot Study

O'Mahoney, Paul R A; Trencheva, Koiana; Zhuo, Changhua; Shukla, Parul J; Lee, Sang W; Sonoda, Toyooki; Milsom, Jeffrey W
BACKGROUND:High-quality images can be readily captured during laparoscopic colon surgery, but there are no guidelines for documentation of these video data or how to best measure surgical quality from an operative video. This study evaluates the feasibility and compliance in documenting key steps during laparoscopic right hemicolectomy and sigmoid colectomy. MATERIALS AND METHODS/METHODS:A retrospective review of previously recorded videos of patients undergoing laparoscopic right hemicolectomy or sigmoid colectomy from September to December 2011 in a single institution was performed. Patients' demographics, intraoperative features, postoperative complications, and variables for video recording and editing were collected. Compliance of key surgical steps was assessed using a checklist by two independent surgeons. RESULTS:Sixteen laparoscopic operations (seven right hemicolectomies and nine sigmoid colectomies) were recorded. Twelve (75%) were laparoscopic-assisted, and four (25%) were hand-assisted laparoscopic operations. Compliance with key surgical steps in laparoscopic right hemicolectomy and sigmoid colectomy was demonstrated in the majority of patients, with steps ranging in compliance from 42.9% to 100% and from 77.8% to 100%, respectively. The edited video had a median duration of 3 minutes 47 seconds (range, 1 minute 44 seconds-5 minutes 38 seconds) with a production time of nearly 1 hour and a resolution of 1440 × 1080 pixels. CONCLUSIONS:Key surgical steps during laparoscopic right hemicolectomy and sigmoid colectomy can be documented and edited into a short representative video. Standardization of this process should allow video documentation to improve quality in laparoscopic colon surgery.
PMID: 26375772
ISSN: 1557-9034
CID: 3525422

Reply to Letter: "Identifying Important Predictors for Anastomotic Leak After Colon and Rectal Resection: Prospective Study on 616 Patients" [Letter]

Trencheva, Koianka; Morrissey, Kevin P; Wells, Martin; Mancuso, Carol A; Lee, Sang W; Sonoda, Toyooki; Michelassi, Fabrizio; Charlson, Mary E; Milsom, Jeffrey W
PMID: 24487748
ISSN: 1528-1140
CID: 3525382

Reply to letter: "identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients" [Letter]

Trencheva, Koianka; Morrissey, Kevin P; Wells, Martin; Mancuso, Carol A; Lee, Sang W; Sonoda, Toyooki; Michelassi, Fabrizio; Charlson, Mary E; Milsom, Jeffrey W
PMID: 24100340
ISSN: 1528-1140
CID: 3525372

Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas

Stamos, Michael J; Snyder, Michael; Robb, Bruce W; Ky, Alex; Singer, Marc; Stewart, David B; Sonoda, Toyooki; Abcarian, Herand
BACKGROUND:Although interest in sphincter-sparing treatments for anal fistulas is increasing, few large prospective studies of these approaches have been conducted. OBJECTIVE:The study assessed outcomes after implantation of a synthetic bioabsorbable anal fistula plug. DESIGN/METHODS:A prospective, multicenter investigation was performed. SETTING/METHODS:The study was conducted at 11 colon and rectal centers. PATIENTS/METHODS:Ninety-three patients (71 men; mean age, 47 years) with complex cryptoglandular transsphincteric anal fistulas were enrolled. Exclusion criteria included Crohn's disease, an active infection, a multitract fistula, and an immunocompromised status. INTERVENTION/METHODS:Draining setons were used at the surgeon's discretion. Patients had follow-up evaluations at 1, 3, 6, and 12 months postoperatively. MAIN OUTCOME MEASURES/METHODS:The primary end point was healing of the fistula, defined as drainage cessation plus closure of the external opening, at 6 and 12 months. Secondary end points were fecal continence, duration of drainage from the fistula, pain, and adverse events during follow-up. RESULTS:Thirteen patients were lost to follow-up and 21 were withdrawn, primarily to undergo an alternative treatment. The fistula healing rates at 6 and 12 months were 41% (95% CI, 30%-52%; total n = 74) and 49% (95% CI, 38%-61%; total n = 73). Half the patients in whom a previous treatment failed had healing. By 6 months, the mean Wexner score had improved significantly (p = 0.0003). By 12 months, 93% of patients had no or minimal pain. Adverse events included 11 infections/abscesses, 2 new fistulas, and 8 total and 5 partial plug extrusions. The fistula healed in 3 patients with a partial extrusion. LIMITATIONS/CONCLUSIONS:The study was nonrandomized and had relatively high rates of loss to follow-up. CONCLUSION/CONCLUSIONS:Implantation of a synthetic bioabsorbable fistula plug is a reasonably efficacious treatment for complex transsphincteric anal fistulas, especially given the simplicity and low morbidity of the procedure.
PMID: 25664714
ISSN: 1530-0358
CID: 3525412

Laparoscopic resection of t4 colon cancers: is it feasible?

Shukla, Parul J; Trencheva, Koiana; Merchant, Chetan; Maggiori, Leon; Michelassi, Fabrizio; Sonoda, Toyooki; Lee, Sang W; Milsom, Jeffrey W
BACKGROUND:Laparoscopic surgical treatment of T4 cancers remains a concern that is mostly associated with technical feasibility, high conversion rate, inadequate oncologic clearance, and surgical outcome. OBJECTIVE:The purpose of this work was to evaluate the short- and long-term clinical and oncologic outcomes after laparoscopic and open surgeries for T4 colon cancers. DESIGN/METHODS:This was a retrospective study of patients with T4 colon cancer without metastasis (M0) who had laparoscopic or open surgery from 2003 to 2011. SETTING/METHODS:The study was conducted at a single institution. PATIENTS/METHODS:A total of 83 patients with pT4 colon cancer were included. MAIN OUTCOME MEASURES/METHODS:R0 resection rate, morbidity and mortality within 30 postoperative days, overall survival, and disease-free survival were measured. RESULTS:Laparoscopic surgery was performed on 61 and open surgery on 22 patients. The groups were similar in overall staging (p = 0.461), with 35 (42%) of the patients at stage 2 and 48 (58%) at stage 3. A complete R0 resection was achieved in 61 (100%) of the patients who underwent laparoscopic surgery and in 21 (96%) of the patients who underwent open surgery (p = 0.265). The average number of lymph nodes harvested was 21 in the laparoscopic group and 24 in the open group (p = 0.202). Thirty-day morbidity rate was similar between the groups (p = 0.467), and the mortality rate was 0. The length of hospital and postsurgical stay was significantly shorter in the laparoscopic group (p = 0.002 and p = 0.008). The 3-year overall survival rates between the groups were 82% (range, 71%-93%) for patients who underwent laparoscopic surgery and 81% (range, 61%-100%) for those who underwent open surgery (p = 0.525), and disease-free survival was 67% (range, 54%-79%) for laparoscopic surgery and 64% (range, 43%-86%) for open surgery (p = 0.848). The follow-up time was 40 ± 25 in months in the laparoscopic group and 34 ± 26 months in the open surgery group (p = 0.325). LIMITATIONS/CONCLUSIONS:This was a retrospective study at a single institution. CONCLUSIONS:The study shows that laparoscopic surgery is feasible in T4 colon cancers. With comparable clinical and oncologic outcomes, this study suggests that laparoscopy may be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery (see Video, Supplemental Digital Content 1,
PMID: 25489691
ISSN: 1530-0358
CID: 3525402